Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain

NCT01967017 | Withdrawn Phase 4

• 1 other identifier: NA_00078756
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.

Conditions

IUD Insertion Complication; Pain Control

Keywords

Intrauterine device; Paracervical block

Outcome Measures

Primary Outcomes (1)

• Pain at time of IUD insertion

  Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment

  During IUD insertion (no further follow up after patient leaves ofice)

Secondary Outcomes (1)

• Pain at other time points of pelvic exam

  During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office)

Other Outcomes (1)

• Ease of insertion

  Within 15 minutes of IUD insertion

Study Arms (2)

Lidocaine

EXPERIMENTAL

Paracervical block using 15 mL of 1 % lidocaine

Drug: Lidocaine

Placebo

PLACEBO COMPARATOR

paracervical block using 15 mL of bacteriostatic saline

Drug: Placebo

Interventions

Lidocaine DRUG

Lidocaine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous and "functionally nulliparous" women receiving their first IUD. "Functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as \<4 cm dilation).
• English speaking

You may not qualify if:

• Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD
• chronic narcotic use, current or past history of illegal drug use (excluding marijuana)
• allergy to lidocaine

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: October 22, 2013
• Study Start: June 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 12, 2017

Record last verified: 2017-06

Locations

US (1)